Scientist, Bioanalytical & Molecular Assays, Centralized Bioanalytical Outsourcing

The Role:

The Scientist will be responsible to support the protein quantification and proteomics analysis using Mass spectrometry for PK and PD studies, ensuring the timely and efficient management of critical reagents used in the development, validation, and execution of bioanalytical and molecular assays to support clinical assays at Moderna. The successful candidate will work closely with cross-functional teams for protein analysis, qualify critical reagents, as well as establish and maintain robust systems for their monitoring, tracking, and storage. This is in person laboratory based position located in Norwood, MA.

Here's What You’ll Do:

• Support LC-MS based protein quantification/proteomics assay development, validation and sample analysis under regulatory compliance.

• A solid background in modern analytical techniques used in the analysis of mRNA-based therapeutic products is essential.

• Maintain a robust system for the monitoring, tracking, and storage of critical reagents to ensure their availability and quality. Support reagent characterization to generate CoA documentation.

• Knowledge of peptide/proteins, aptamer-antibody based conjugation systems for DNA, RNA, and Protein/antibodies. 

• Maintain a database of Reference standards/reagents, including their specifications, source, usage, and expiration dates.

• Conduct regular audits of critical reagent inventory and work with cross-functional teams to manage the procurement and disposition of the reagents.

• Vendor management to ensure the availability and quality of critical reagents.

• Develop and implement policies, procedures, and training programs to ensure compliance with regulatory requirements and industry best practices.

• Collaborate with cross-functional teams to develop reagent-specific risk assessments and mitigation strategies.

• Monitor industry trends and advancements in critical reagent management and implement the best practices to improve efficiency and effectiveness.

Here’s What You’ll Need (Basic Qualifications)

• Ph.D. in a scientific field, such as chemistry, biochemistry, or biology with 3+ years of experience in Bioanalytical Sciences/regulated bioanalysis. M.S. with at least 7 years of bioanalytical experience will also be considered.

• Strong knowledge of critical reagents management as well as current industry best practices and regulatory requirements.

• Deep understanding of Proteomics/Protein mass spectrometry for PK and biomarker analysis

• Demonstrated ability to work collaboratively with cross-functional teams to achieve shared goals.

• Excellent organizational, analytical, and problem-solving skills.

• Proven ability to manage multiple projects simultaneously and prioritize tasks in a fast-paced environment.

Here’s What You’ll Bring to the Table (Preferred Qualifications):

• Experience with the Biophysical Characterization of Biologics (LCMS, SDS-PAGE, cIEF, SPR, BLI, SEC-HPLC, SEC-MALS, UV-VIS)

• Experience working in a GLP environment (ELN/LIMS/automation)

• Experience with HRMS and software for protein analysis/characterization

At Moderna, we believe that when you feel your best, you can do your best work.  That’s why our US benefits and global well-being resources are designed to support you—at work, at home, and everywhere in between.

• Best-in-class healthcare coverage, plus a suite of voluntary benefit programs to support your unique needs
• A holistic approach to well-being, with access to fitness, mindfulness, and mental health support
• Lifestyle Spending Accounts to personalize your well-being journey
• Family planning and adoption benefits
• Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
• Savings and investment opportunities
• Location-specific perks and extras

About Moderna

Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.  

By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that care